Clinical Efficacy and Safety of NEOIAL HC (Hyaluronic Acid + Collagen) for Intra-articular Use in the Treatment of Severe Knee Osteoarthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- VAS score
研究概览
简要总结
Osteoarthritis (OA) is one of the most frequent causes of pain and disability in adults. According to the Osteoarthritis Research Society International (OARSI), at least 40% of people over the age of 65 suffer from symptomatic osteoarthritis of the hip or knee. Knee osteoarthritis (OA) is the eleventh leading cause of years lived with disability according to the World Health Organization.
The guidelines show that treatment with intra-articular injections of hyaluronic acid (HA) leads to a slow, prolonged pain relief (up to six months after the first injection); On the other hand, there is little evidence in the literature about the intra-articular use of isolated collagen or in combination with hyaluronic acid in the treatment of knee osteoarthritis.
The present study showed a clinically good safety profile and provided preliminary evidence of the efficacy of NEOIAL HC for the treatment of symptomatic knee OA
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Kellegren radiographic stage 3-4
排除标准
- •presence of joint effusion,
- •VAS score <3 according to the American College of Rheumatology Criteria
- •neoplasms,
- •haematological diseases,
- •specific rheumatological pathologies,
- •bleeding disorders, local infections,
- •refusal or non-compliance of the patient,
- •candidacy for knee joint replacement or any intra-articular injection during the previous year,
- •addiction to opioid drugs,
- •recent heart attack or stroke.
结局指标
主要结局
VAS score
时间窗: 6 months
The primary objective in the study was to evaluate the mean changes from baseline at Month 3 in VAS Pain Subscale Score
次要结局
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(6 months)
- Western Ontario McMaster Universities (WOMAC®) VA3.1(6 months)
- Lequesne(6 months)